Quality of life among borderline ovarian tumor survivors: A comparison with survivors of early-stage ovarian cancer and a cancer-free population: A cross-sectional population-based PROFILES study.

OBJECTIVE: This study assessed the health-related quality of life (HRQo) of women surviving a borderline ovarian tumor (BOT) in comparison with early-stage ovarian cancer survivors treated surgically alone and with a matched cancer-free population. METHODS: Survivors of BOT and ovarian cancer were invited in two Dutch cross-sectional, population-based studies. Ovarian cancer survivors with tumor stage I who were treated surgically only were included. A random sample from the cancer-free population was matched on sex, age and education to the sample of BOT survivors. The EORTC QLQ-C30 (version 3.0) and the EORTC QLQ-OV28 were completed by the cancer-free population and the BOT and ovarian cancer survivors in study 1 and 2. The Hospital Anxiety and Depression Scale (HADS) was only completed by the cancer-free population and the survivors of BOT and ovarian cancer in study 1. BOT survivors were compared to early-stage ovarian cancer survivors and the general population using linear regression analyses and effect sizes regarding clinical importance. RESULTS: 83 BOT (42%), 88 early-stage ovarian cancer survivors (52%), and 82 women from the general population were included. In most HRQoL domains, BOT survivors were not significantly different from early-stage ovarian cancer survivors and the cancer-free population, except that BOT survivors reported significantly less insomnia than early-stage ovarian cancer survivors and more dyspnea than the cancer-free population (small clinical difference). CONCLUSION: In general, BOT survivors' HRQoL lies between the HRQoL of early-stage ovarian cancer survivors and of the cancer-free population, but clinical effect sizes between the groups were mostly only trivial.

Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial.

BACKGROUND: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. METHODS: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8-11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. RESULTS: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). CONCLUSIONS AND RELEVANCE: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.

Real-life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study (RESPONSE trial).

BACKGROUND: This study aimed to describe the treatment strategies and outcomes for women with newly diagnosed advanced high-grade serous or endometrioid ovarian cancer (OC). METHODS: This observational study collected real-world medical record data from eight Western countries on the diagnostic workup, clinical outcomes, and treatment of adult women with newly diagnosed advanced (Stage III-IV) high-grade serous or endometrioid OC. Patients were selected backward in time from April 1, 2018 (the index date), with a target of 120 patients set per country, followed for ≥20 months. RESULTS: Of the 1119 women included, 66.9% had Stage III disease, 11.7% had a deleterious BRCA mutation, and 26.6% received bevacizumab; 40.8% and 39.3% underwent primary debulking surgery (PDS) and interval debulking surgery (IDS), respectively. Of the patients who underwent PDS, 55.5% had no visible residual disease (VRD); 63.9% of the IDS patients had no VRD. According to physician-assessed responses (at the first assessment after diagnosis and treatment), 53.2% of the total population had a complete response and 25.7% had a partial response to first-line chemotherapy after surgery. After ≥20 months of follow-up, 32.9% of the patients were disease-free, 46.4% had progressive disease, and 20.6% had died. Bevacizumab use had a significant positive effect on overall survival (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91; p = .01). A deleterious BRCA status had a significant positive effect on progression-free survival (HR, 0.60; 95% CI, 0.41-0.84; p < .01). CONCLUSIONS: Women with advanced high-grade serous or endometrioid OC have a poor prognosis. Bevacizumab use and a deleterious BRCA status were found to improve survival in this real-world population. LAY SUMMARY: Patients with advanced (Stage III or IV) ovarian cancer (OC) have a poor prognosis. The standard treatment options of surgery and chemotherapy extend life beyond diagnosis for 5 years or more in only approximately 45% of patients. This study was aimed at describing the standard of care in eight Western countries and estimating how many patients who are diagnosed with high-grade serous or endometrioid OC could potentially be eligible for first-line poly(adenosine diphosphate ribose) polymerase inhibitor (PARPi) maintenance therapy. The results highlight the poor prognosis for these patients and suggest that a significant proportion (79%) would potentially be eligible for first-line PARPi maintenance treatment.

The Paget Trial: topical 5% imiquimod cream for noninvasive vulvar Paget disease.

BACKGROUND: Vulvar Paget disease is an extremely rare skin disorder, which is most common in postmenopausal women. Most vulvar Paget disease cases are noninvasive; however, it may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The current treatment of choice for noninvasive vulvar Paget disease is wide local excision, which is challenging because of extensive intraepithelial spread and may cause severe morbidity. Recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. Imiquimod, a topical immune response modifier, has been shown to be effective in a few studies and case reports, and is a promising new treatment modality. OBJECTIVE: To prospectively investigate the efficacy, safety, and effect on quality of life of a standardized treatment schedule with 5% imiquimod cream in patients with noninvasive vulvar Paget disease. STUDY DESIGN: The Paget Trial is a multicenter prospective observational clinical study including 7 tertiary referral hospitals in the Netherlands. A total of 24 patients with noninvasive vulvar Paget disease were treated with topical 5% imiquimod cream 3 times a week for 16 weeks. The primary efficacy outcome was the reduction in lesion size at 12 weeks after the end of treatment. Secondary outcomes were safety, clinical response after 1 year, and quality of life. Safety was assessed by evaluation of adverse events and tolerability of treatment. Quality of life was investigated with 3 questionnaires taken before, during, and after treatment. RESULTS: Data were available for 23 patients, 82.6% of whom responded to therapy. A complete response was reported in 12 patients (52.2%), and 7 patients (30.4%) had a partial response. A histologic complete response was observed in 10 of the 12 patients with a complete response. Patients experienced side effects such as fatigue (66.7%-70.9%) and headaches (16.7%-45.8%), and almost 80% needed painkillers during treatment. Eight patients (34.8%) adjusted the treatment protocol to 2 applications a week, and 3 patients (13.0%) stopped treatment because of side effects after 4 to 11 weeks. Treatment improved quality of life, whereas a slight, temporary negative impact was observed during treatment. Two patients with a complete response developed a recurrence within 1 year after treatment. Follow-up showed 6 patients with a noninvasive recurrence after a median of 31 months (14-46 months) after the end of treatment. CONCLUSION: Topical 5% imiquimod cream can be an effective and safe treatment alternative for noninvasive vulvar Paget disease, particularly when compared with treatment with surgical excision.

Cancer-related psychosocial factors and self-reported changes in lifestyle among gynecological cancer survivors: cross-sectional analysis of PROFILES registry data.

PURPOSE: Obesity is prevalent in gynecological cancer survivors and is associated with impaired health outcomes. Concerns due to cancer and its treatment may impact changes in lifestyle after cancer. This study aimed to assess the association between cancer-related psychosocial factors and changes in physical activity and diet, 18 months after initial treatment among gynecological cancer survivors. METHODS: Cross-sectional data from the ROGY Care study were used, including endometrial and ovarian cancer patients treated with curative intent. The Impact of Cancer Scale (IOCv2) was used to assess cancer-related psychosocial factors. Self-reported changes in nutrients/food groups and in physical activity post-diagnosis were classified into change groups (less/equal/more). Multivariable logistic regression models were used to assess associations. RESULTS: Data from 229 cancer survivors (59% endometrial, 41% ovarian, mean age 66 ± 9.5, 70% tumor stage I) were analyzed. In total, 20% reported to eat healthier from diagnosis up to 18 months after initial treatment, 17% reported less physical activity and 20% more physical activity. Health awareness (OR 2.79, 95% CI: 1.38; 5.65), body change concerns (OR 3.04 95% CI: 1.71; 5.39), life interferences (OR 4.88 95% 2.29; 10.38) and worry (OR 2.62, 95% CI: 1.42; 4.85) were significantly associated with less physical activity up to 18 months after initial treatment whereby gastrointestinal symptoms were an important confounder. CONCLUSION(S): This study underlines the need to raise awareness of the benefits of a healthy lifestyle and to provide tailored lifestyle advice, taking into account survivors' health awareness, body change concerns, life interferences, worry and gastrointestinal symptoms, in order to improve health behavior among gynecological cancer survivors. TRIAL REGISTRATION: http://clinicaltrials.gov Identifier: NCT01185626, August 20, 2010.

Impact of hormonal biomarkers on response to hormonal therapy in advanced and recurrent endometrial cancer.

BACKGROUND: Approximately 20% of women with endometrial cancer have advanced-stage disease or suffer from a recurrence. For these women, prognosis is poor, and palliative treatment options include hormonal therapy and chemotherapy. Lack of predictive biomarkers and suboptimal use of existing markers for response to hormonal therapy have resulted in overall limited efficacy. OBJECTIVE: This study aimed to improve the efficacy of hormonal therapy by relating immunohistochemical expression of estrogen and progesterone receptors and estrogen receptor pathway activity scores to response to hormonal therapy. STUDY DESIGN: Patients with advanced or recurrent endometrial cancer and available biopsies taken before the start of hormonal therapy were identified in 16 centers within the European Network for Individualized Treatment in Endometrial Cancer and the Dutch Gynecologic Oncology Group. Tumor tissue was analyzed for estrogen and progesterone receptor expressions and estrogen receptor pathway activity using a quantitative polymerase chain reaction-based messenger RNA model to measure the activity of estrogen receptor-related target genes in tumor RNA. The primary endpoint was response rate defined as complete and partial response using the Response Evaluation Criteria in Solid Tumors. The secondary endpoints were clinical benefit rate and progression-free survival. RESULTS: Pretreatment biopsies with sufficient endometrial cancer tissue and complete response evaluation were available in 81 of 105 eligible cases. Here, 22 of 81 patients (27.2%) with a response had estrogen and progesterone receptor expressions of >50%, resulting in a response rate of 32.3% (95% confidence interval, 20.9-43.7) for an estrogen receptor expression of >50% and 50.0% (95% confidence interval, 35.2-64.8) for a progesterone receptor expression of >50%. Clinical benefit rate was 56.9% for an estrogen receptor expression of >50% (95% confidence interval, 44.9-68.9) and 75.0% (95% confidence interval, 62.2-87.8) for a progesterone receptor expression of >50%. The application of the estrogen receptor pathway test to cases with a progesterone receptor expression of >50% resulted in a response rate of 57.6% (95% confidence interval, 42.1-73.1). After 2 years of follow-up, 34.3% of cases (95% confidence interval, 20-48) with a progesterone receptor expression of >50% and 35.8% of cases (95% confidence interval, 20-52) with an estrogen receptor pathway activity score of >15 had not progressed. CONCLUSION: The prediction of response to hormonal treatment in endometrial cancer improves substantially with a 50% cutoff level for progesterone receptor immunohistochemical expression and by applying a sequential test algorithm using progesterone receptor immunohistochemical expression and estrogen receptor pathway activity scores. However, results need to be validated in the prospective Prediction of Response to Hormonal Therapy in Advanced and Recurrent Endometrial Cancer (PROMOTE) study.

Changes in internet use and wishes of cancer survivors: A comparison between 2005 and 2017.

BACKGROUND: Given the major changes in internet use for health communication, the objective of the current study was to compare the internet use and wishes of cancer survivors between 2005 and 2017. METHODS: The authors drew a sample of 390 patients in 2005 and 539 patients in 2017 who were diagnosed with breast (128 patients in 2005 and 143 patients in 2017), prostate (96 patients in 2005 and 126 patients in 2017), or gynecologic (89 patients in 2005 and 188 patients in 2017) cancer or lymphoma (77 patients in 2005 and 82 patients in 2017) in 4 different hospitals for the periods 2002 through 2004 and 2014 through 2016. These patients were sent a paper-based questionnaire that contained 45 questions regarding demographics and 4 functions of internet use: content, communication, community, and e-health. RESULTS: The response in 2017 (53%) was lower than that in 2005 (75%). Survivors browsed the internet most frequently to search for information regarding cancer shortly after being diagnosed and while waiting for treatment. There was little change noted with regard to the relative importance attached to the various subjects. In 2017, significant increases were evident with regard to finances (+33%), health care insurance (+29%), and genetics and/or heritability (+27%). The wishes expressed in 2005 by patients were realized in part in 2017. CONCLUSIONS: A significant sample of cancer survivors in the Netherlands have indicated that the internet is an important source of information regarding their illness. However, little change was evident over the past 15 years with regard to patients' priorities regarding their wishes for internet use. The wishes of users in 2005 were found to accurately reflect the internet use of the majority of patients in 2017. The results of the current study support the belief that health care professionals should expand their online services and tailor them toward the needs and wishes of their patients.

Development of a decision aid for primary treatment of patients with advanced-stage ovarian cancer.

INTRODUCTION: Despite renewed treatment options for advanced epithelial ovarian cancer, survival remains poor. The Patient Association and the Gynecological Oncology Working Party in the Netherlands have identified a need for a tool to improve shared decision-making. The aim of this study was to develop an evidence-based online decision aid for patients with advanced epithelial ovarian cancer and their medical team. METHODS: First, we identified the patients' and clinicians' needs using surveys and in-depth interviews. Second, we conducted multidisciplinary face-to-face meetings with representatives from all stakeholders (clinicians and patient representatives) to determine the content of the decision aid. Third, we developed the decision aid using standardized criteria and national guidelines. Finally, we tested the usability of the tool with patients and clinicians who participated in the needs assessment. RESULTS: Patients and clinicians indicated the need for more sources of reliable information that include all treatment options available in the Netherlands. Although most interviewees were satisfied with the level of information available at the time of their own treatment, the majority (90%) of the patients stated that no choice of treatment was offered. We developed a consultation sheet and an online decision aid based on patient interviews and team discussions. The sheet contains a summary of all treatment options and login codes for the decision aid; it will be offered to patients at their first consultation. The decision aid can be used at home and includes information about epithelial ovarian cancer and all available treatment options and questions about quality of life and treatment preferences, delivering a personalized summary for discussion during the following consultation about the primary treatment choices. DISCUSSION: In cooperation with patients and clinicians, we developed a decision aid for advanced-stage epithelial ovarian cancer patients and their medical team to support shared decision-making, based on a confirmed need for more extensive information sources. The decision aid is currently under assessment in a multicenter implementation trial.

Patients' information coping styles influence the benefit of a survivorship care plan in the ROGY Care Trial: New insights for tailored delivery.

BACKGROUND: In efforts to improve the implementation of survivorship care plans (SCPs), the authors assessed whether the impact of SCPs on patient-reported outcomes differed between patients with an information-seeking coping style (monitoring) versus those with an information-avoiding coping style (blunting). METHODS: In the Registration System Oncological Gynecology (ROGY) Care Trial, 12 hospitals in the Netherlands were randomized to deliver SCP care or usual care. All patients with newly diagnosed endometrial and ovarian cancer in the SCP care arm received an SCP that was generated automatically by their oncology provider through the web-based ROGY registration system. Outcomes (satisfaction with information provision and care, illness perceptions, and health care use) were measured directly after initial treatment and after 6, 12, and 24 months. Information coping style was measured at 12 months after initial treatment. RESULTS: Among patients who had a monitoring coping style (N = 123), those in the SCP care arm reported higher satisfaction with information provision (mean score: 73.9 vs 63.9, respectively; P = .04) and care (mean score: 74.5 vs 69.2, respectively; P = .03) compared with those in the usual care arm. Among patients who had a blunting coping style (N = 102), those in the SCP care arm reported a higher impact of the disease on life (mean score: 5.0 vs 4.5, respectively; P = .02) and a higher emotional impact of the disease (mean score: 5.4 vs 4.2, respectively; P = .01) compared with those in the usual care arm. CONCLUSIONS: SCPs may be beneficial for patients who desire information about their disease, whereas SCPs may be less beneficial for patients who avoid medical information, suggesting a need for tailored SCP delivery to improve survivorship care.

Changes in health-related quality of life among gynecologic cancer survivors during the two years after initial treatment: a longitudinal analysis.

Background: While many cancer survivors experience persistent impairments in health-related quality of life (HRQoL) for extended periods of time, others recover soon after treatment. The aim of this research is to assess changes in health-related quality of life in endometrial and ovarian cancer survivors during two years post initial treatment, and to assess clinical and sociodemographic characteristics associated with those changes. Methods: This prospective population-based cohort study includes longitudinal data of endometrial (N = 221) and ovarian (N = 174) cancer survivors diagnosed between 2011 and 2014. The EORTC QLQ-C30 functioning scales were used to assess HRQoL after initial treatment and after 6, 12 and 24 months. Clinical (stage, treatment and comorbidities) and sociodemographic (age, marital status and socio-economic status) characteristics were obtained from the Netherlands Cancer Registry and through self-administered questionnaires. Linear mixed models were used to assess changes in HRQoL over time and characteristics associated with these changes. Results: Among both endometrial and ovarian cancer patients, HRQoL improved within the first 6 months after initial treatment. Changes in HRQoL were mainly associated with clinical characteristics including comorbidities, treatment and tumor stage, and to a lesser extent with sociodemographic characteristics such as socioeconomic status. However, these associations varied per tumor type. Endometrial cancer survivors, who received radiotherapy and had no comorbidities, reported greater improvements in some HRQoL scales over time. Ovarian cancer patients who received chemotherapy and with advanced tumor stages reported poorer functioning during treatment. Most functioning domains (global health, physical and role functioning) recovered to levels of patients without chemotherapy or with early-stage disease after 12 months, but cognitive and social functioning remained impaired. Conclusion: Some subgroups of patients, including those with multiple comorbidities, with an advanced tumor stage and who received chemotherapy, may be in need of additional support as they are less likely to show improvements in HRQoL over time.

The role of positive psychological changes in anxiety and depression of patients with ovarian tumors and their partners: an observational study from the population-based PROFILES registry.

PURPOSE: It is unknown whether positive psychological changes (e.g., in life perspective, self-perception, and social relationships) after being diagnosed with ovarian cancer can reduce anxiety and depression in patients and their partners. The first aim of the present study was to assess differences in anxiety and depression between patients diagnosed with an ovarian tumor and their partners. The second aim was to explore the mutual associations of patients' and partners' posttraumatic growth and their anxiety and depressive symptoms. METHODS: Participants included 130 Dutch couples of which one partner was diagnosed with a borderline ovarian tumor or ovarian cancer between 2000 and 2010, as registered by the Netherlands Cancer Registry. In September 2011, a questionnaire was sent including the Hospital Anxiety and Depression Scale (anxiety and depression) and Cancer Survivors (Partners) Unmet Needs measure (positive psychological changes). RESULTS: A one-way multivariate analysis of variance showed that patients reported higher anxiety than partners, without differences in depression. Contrasting to our expectations, an actor-partner interdependence model revealed no mutual dyadic associations between positive psychological changes and anxiety or depressive symptoms. CONCLUSIONS: Based on these findings, positive psychological change seems to be an independent construct unrelated to anxiety or depression in couples diagnosed with ovarian tumors. Still, as ovarian tumor patients and partners suffer from high anxiety and depression, further research investigating how these feelings can be reduced in couples dealing with an ovarian tumor is necessary.

Illness perceptions are associated with higher health care use in survivors of endometrial cancer-a study from the population-based PROFILES registry.

OBJECTIVES: According to the Common Sense Model of self-regulation, cancer survivors construct perceptions of their illness as a (mal)adaptive mechanism. These perceptions might impact on health care use. We aimed to explore the association between illness perceptions and health care use in stage I-II endometrial cancer (EC) survivors, and whether these associations differed by time since diagnosis. METHODS: A survey was conducted in 2008 by the population-based PROFILES registry among EC survivors diagnosed between 1999 and 2007. Survivors (n = 742, 77% response) completed the Brief Illness Perception Questionnaire (BIPQ) and questions on health care use in the past 12 months. Clinical data were accessed from the Netherlands Cancer Registry. Multiple logistic regression was used to evaluate the relationship between illness perceptions and health care use. RESULTS: Between 15 and 22% of the survivors had negative illness perceptions. Survivors with more negative perceptions on consequences, timeline, treatment control, identity, cognitive representation, concern, emotion, and emotional representation were more likely to make ≥ 1 visit to their family physician/general practitioner in relation to their cancer when compared with survivors with more positive illness perceptions. More negative perceptions on consequences, timeline, identity, and concern were associated with ≥ 2 general or cancer-related visits to the medical specialists. The association between negative illness perceptions and health care use was more prominent among long-term (>5 years post-diagnosis) EC survivors. CONCLUSIONS: Negative illness perceptions among EC survivors were associated with higher health care use. For individuals with maladaptive illness perceptions, visits to their health care provider may reduce worry about their illness. Future research might address the effects of intervening in maladaptive illness perceptions on use of health care in this category of survivors.

Course of chemotherapy-induced peripheral neuropathy and its impact on health-related quality of life among ovarian cancer patients: A longitudinal study.

OBJECTIVE: Chemotherapy-induced peripheral neuropathy (CIPN) presents itself as sensory peripheral neuropathy (SPN) or motor peripheral neuropathy (MPN). Our aim was to examine the course of SPN and MPN, and their impact on health-related quality of life (HRQoL) among ovarian cancer patients. METHODS: All newly diagnosed ovarian cancer patients from twelve hospitals in the South of the Netherlands were eligible for participation. Patients (N=174) completed questions on CIPN (EORTC QLQ-OV28) and HRQoL (EORTC QLQ-C30) after initial treatment and at 6, 12, and 24months (response rates were 70%, 71%, 58%, and 43% respectively). RESULTS: Generalized linear mixed models showed that among chemotherapy-treated patients (N=98), SPN levels were stable over time. For MPN, symptoms significantly improved at 12months. At 2years, 13% still reported high SPN. Also, 11% still reported high MPN. Regarding HRQoL, patients with high SPN reported a worse physical, role, emotional, social, and cognitive functioning compared to those with low SPN. Moreover, those who changed from low to high SPN over time worsened on physical functioning. For MPN, a worse global quality of life and a worse functioning was reported among patients with high MPN. Also, those who changed from low to high MPN over time worsened on global quality of life and on physical, role, social, and cognitive functioning. CONCLUSIONS: Among chemotherapy-treated ovarian cancer patients, SPN levels were stable over time. In contrast, MPN symptoms significantly improved at 12months. These symptoms seriously impacted HRQoL. Future studies should examine the impact of different treatment decisions and alterations on CIPN, so recommendations can be made to reduce CIPN (prevalence).

Recurrent Cancer Is Associated With Dissatisfaction With Care-A Longitudinal Analysis Among Ovarian and Endometrial Cancer Patients.

OBJECTIVE: The primary aim of this study was to assess the longitudinal impact of a recurrence of gynecological cancer on satisfaction with information provision and care. The secondary aim was to assess the impact of a recurrence on illness perceptions, anxiety, and depression and health-related quality of life. METHODS: This study is a longitudinal analysis from the ROGY Care trial, conducted between 2011 and 2014, including patients with endometrial (n = 215) and ovarian (n = 149) cancer. Patients were invited to complete questionnaires directly after initial treatment and after 6, 12, and 24 months. Satisfaction with information provision and care, illness perceptions, anxiety, and depression were compared before and after the recurrence. Linear mixed-model analyses were conducted to assess the differences in outcomes of patients with a recurrence compared with patients without a recurrence. RESULTS: During 2-year follow-up, 25 patients with endometrial cancer (12%) and 64 patients with ovarian cancer (43%) had recurrent disease, of whom 9 endometrial and 26 ovarian cancer patients completed at least 1 questionnaire after their recurrence was determined. Patients reported lower satisfaction with care after the diagnosis of a recurrence (doctor interpersonal skills, exchange of information between caregivers, and general satisfaction with care) compared with patients without recurrence. In addition, patients reported lower health-related quality of life, more anxiety and depression, and more threatening illness perceptions after diagnosis of a recurrence. CONCLUSIONS: After diagnosis of recurrent disease, endometrial and ovarian cancer patients were less satisfied with care compared with patients without a recurrence. Our findings suggest that patients with recurrent cancer are in need of care that is better tailored to their needs.

Survivorship care plans have a negative impact on long-term quality of life and anxiety through more threatening illness perceptions in gynecological cancer patients: the ROGY care trial.

PURPOSE: Prior results from the registration system oncological gynecology (ROGY) care trial showed that survivorship care plans (SCPs) increased threatening illness perceptions in gynecological cancer survivors, but it remained unclear whether this would result in poorer physical and psychosocial outcomes. The aim of the current study is to assess the direct and indirect effects of SCPs on health-related quality of life (HRQoL) and anxiety and depression, through illness perceptions. METHODS: Twelve hospitals in the South of the Netherlands were randomized to providing 'SCP care' or 'usual care.' Newly diagnosed endometrial and ovarian cancer patients completed questionnaires after initial treatment (endometrial, 221 [75%]; ovarian, 174 [71%]) and after 6, 12, and 24 months. SCPs were automatically generated after initial treatment by the oncology providers through the web-based ROGY. Illness perceptions were measured after initial treatment and HRQoL and anxiety and depression after 6, 12, and 24 months. RESULTS: Structural equation models showed that endometrial cancer patients who experienced more symptoms or concern due to the SCP reported worse social functioning (ß = - 0.82; p = 0.01) and more fatigue, insomnia, pain, and anxiety (ß = 0.58-0.86, p < 0.05) within 12 months after treatment. Ovarian cancer patients who had lower trust that the treatment would cure their disease due to the SCP reported worse emotional functioning 6 months after treatment (ß = 0.27, p = 0.02). CONCLUSIONS: Current results show that SCPs may have negative effects on HRQoL and anxiety in patients who experience more threatening illness perceptions due to the SCP. We should be aware of the potential negative consequences of SCPs. Trial Registration clinicaltrials.gov Identifier: NCT01185626.

Illness perceptions and changes in lifestyle following a gynecological cancer diagnosis: A longitudinal analysis.

OBJECTIVE: This study explores patterns of lifestyle change and whether more threatening illness perceptions are associated with lifestyle changes post-treatment for smoking, alcohol consumption and Body Mass Index (BMI) among gynecological cancer patients. METHODS: In total, 395 cancer patients (N=221 endometrial; N=174 ovarian) were included in this secondary analysis of longitudinal data. Lifestyle outcomes were assessed through self-reported questionnaires after initial treatment and 6, 12, and 18months of follow-up. Illness perceptions were assessed with the Brief Illness Perception Questionnaire (BIPQ). Latent class growth curve analyses were conducted to identify patterns of lifestyle change and linear mixed models using between-subject and within-subject effects to explore the association between BIPQ items and alcohol consumption (glasses/week) and BMI (kg/m2). RESULTS: After initial treatment, 15% (N=57) of the patients smoked, 53% (N=203) drank alcohol, and 60% (N=236) were overweight or obese. Overall, smokers made no considerable changes, but one subgroup of low level smokers reported positive decline. A slight decrease was observed for alcohol consumption among low and moderate level alcohol drinker subgroups, whereas BMI remained stable among endometrial cancer patients and increased for ovarian cancer patients. Moreover, patients with lower trust in their treatment to cure the disease drank more alcohol (ß=0.32 glasses/week [95% CI 0.09; 0.56]). CONCLUSIONS: Change in lifestyle after a gynecological cancer treatment is not self-evident. Moreover, more threatening illness perceptions were not related to a healthier lifestyle. This study underlines the need for lifestyle-promoting activities to facilitate lifestyle improvement among gynecological cancer patients.

Effects of Survivorship Care Plans on patient reported outcomes in ovarian cancer during 2-year follow-up - The ROGY care trial.

OBJECTIVE: The aim of this study was to assess the long-term impact of an automatically generated Survivorship Care Plan (SCP) on patient reported outcomes in ovarian cancer in routine clinical practice. Outcome measures included satisfaction with information provision and care, illness perceptions and health care utilization. METHODS: In this pragmatic cluster randomized trial, twelve hospitals in the South of the Netherlands were randomized to 'SCP care' or 'usual care'. All newly diagnosed ovarian cancer patients in the 'SCP care' arm received an SCP that was automatically generated by the oncology provider, by clicking a button in the web-based Registrationsystem Oncological GYnecology (ROGY). Ovarian cancer patients (N=174, mean age 63.3, SD=11.4; all stages) completed questionnaires directly after initial treatment and after 6, 12 and 24months. RESULTS: First questionnaires were returned from 61 (67%) ovarian cancer patients in the 'SCP care' arm and 113 (72%) patients in the 'usual care' arm. In the 'SCP care' arm, 66% (N=41) of the patients reported receipt of an SCP. No overall differences were observed between the trial arms on satisfaction with information provision, satisfaction with care or health care utilization. Regarding illness perceptions, patients in the 'SCP care' arm had lower beliefs that the treatment would help to cure their disease (overall, 6.7 vs. 7.5, P<0.01). CONCLUSIONS: SCPs did not increase satisfaction with information provision or care in ovarian cancer patients. Our trial results suggest that ovarian cancer patients may not benefit from an SCP. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01185626.

High Incidence of Erysipelas After Surgical Treatment for Vulvar Carcinoma: An Observational Study.

OBJECTIVES: Vulvar carcinoma is mainly treated surgically and has an overall good prognosis. Despite the development of minimally invasive surgical procedures in recent years, morbidity remains significant. The aim of the study was to determine the incidence and risk factors of erysipelas after surgical treatment for vulvar carcinoma. METHODS: This retrospective observational study was performed within the Comprehensive Cancer Centre South. The study included patients (N = 116) who underwent surgery for primary vulvar carcinoma between 2005 and 2012. Patients with International Federation of Gynecology and Obstetrics stage IA and IV were excluded. Clinical and histopathological data were analyzed using logistic regression, χ(2) tests, Fisher exact tests, independent t tests, and nonparametric tests. Primary outcome was the incidence of postoperative erysipelas and determination of risk factors for erysipelas. Secondary outcome included other comorbidities. RESULTS: A total of 23 patients (20%) with vulvar carcinoma had 1 or more episodes of erysipelas. The risk of developing erysipelas was significantly higher in patients who underwent lymph node dissection than in those who underwent sentinel node biopsy (36% [n = 12] and 14% [n = 11], respectively, P = 0.008) and in patients with lymphedema than in those without (30% [n = 7] and 12% [n = 11], respectively, P = 0.048). Patients with diabetes tended to have a higher incidence of erysipelas than those without (28% vs 18%, P = 0.27). CONCLUSIONS: Erysipelas occurs frequently in patients who undergo surgical treatment for vulvar carcinoma. The risk of erysipelas is 3 times higher in patients who undergo lymph node dissection and in those with lymphedema than in those without, and it tends to be high in patients with diabetes.

Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial.

BACKGROUND: The Institute of Medicine recommends Survivorship Care Plans (SCPs) for all cancer survivors. However, it is unclear whether certain patient groups may or may not benefit from SCPs. OBJECTIVE: The aim was to assess whether the effects of an automatically generated paper SCP on patients' satisfaction with information provision and care, illness perceptions, and health care utilization were moderated by disease-related Internet use. METHODS: Twelve hospitals were randomized to either SCP care or usual care in the pragmatic cluster randomized Registrationsystem Oncological GYnecology (ROGY) Care trial. Newly diagnosed endometrial cancer patients completed questionnaires after diagnosis (N=221; response: 74.7%, 221/296), 6 months (n=158), and 12 months (n=147), including patients' satisfaction with information provision and care, illness perceptions, health care utilization (how many times patients visited a medical specialist or primary care physician about their cancer in the past 6 months), and disease-related Internet use (whether patients used the Internet to look for information about cancer). RESULTS: In total, 80 of 221 (36.2%) patients used the Internet to obtain disease-related information. Disease-related Internet use moderated the SCP care effect on the amount of information received about the disease (P=.03) and medical tests (P=.01), helpfulness of the information (P=.01), and how well patients understood their illness (P=.04). All stratified analyses were not statistically significant. However, it appeared that patients who did not seek disease-related information on the Internet in the SCP care arm reported receiving more information about their disease (mean 63.9, SD 20.1 vs mean 58.3, SD 23.7) and medical tests (mean 70.6, SD 23.5 vs mean 64.7, SD 24.9), finding the information more helpful (76.7, SD 22.9 vs mean 67.8, SD 27.2; scale 0-100), and understanding their illness better (mean 6.6, SD 3.0 vs mean 6.1, SD 3.2; scale 1-10) than patients in the usual care arm did. In addition, although all stratified analyses were not significant, patients who did seek disease-related information on the Internet in the SCP care arm appeared to receive less information about their disease (mean 65.7, SD 23.4 vs mean 67.1, SD 20.7) and medical tests (mean 72.4, SD 23.5 vs mean 75.3, SD 21.6), did not find the information more helpful (mean 78.6, SD 21.2 vs mean 76.0, SD 22.0), and reported less understanding of their illness (mean 6.3, SD 2.8 vs mean 7.1, SD 2.7) than patients in the usual care arm did. CONCLUSIONS: Paper SCPs appear to improve the amount of information received about the disease and medical tests, the helpfulness of the information, and understanding of the illness for patients who do not search for disease-related information on the Internet. In contrast, paper SCPs do not seem beneficial for patients who do seek disease-related information on the Internet. TRIAL REGISTRATION: ClinicalTrials.gov NCT01185626; https://clinicaltrials.gov/ct2/show/NCT01185626 (Archived by WebCite at http://www.webcitation.org/6fpaMXsDn).

'There is still a part of me that would love to be the old me again', how do adolescents and young adults (AYA) experience cancer-related bodily changes: a phenomenological interview study.

PURPOSE: Due to the increase in both cancer incidence and overall survival rates, more adolescents and young adults (AYAs) have to live with the effects that their cancer diagnosis and following treatments have on their bodies. This qualitative phenomenological study aimed to gain more insight into the way AYAs experience these effects and how they respond to these effects. METHODS: Semi-structured interviews with a sample of 11 AYAs with an age range of 25-41 years at the time of the interview, who were diagnosed with different types of cancer, were conducted. Participants were recruited via social media and patient associations until data saturation was reached. A topic guide with open-ended questions about lived experiences was used. Interpretative phenomenological analysis (IPA) was performed to analyse the transcripts. RESULTS: We identified six Group Experiential Themes based on different ways AYAs experience their bodies: (1) self-conscious body, (2) vulnerable body, (3) adapting to the body, (4) uncontrollable body, (5) remembering the body and (6) shared bodies. CONCLUSION: This study offers in-depth insight into the bodily experiences of AYAs after cancer and how they respond to these changes from a phenomenological point of view. IMPLICATIONS FOR CANCER SURVIVORS: This knowledge could be beneficial to provide more guidance for AYAs during and after their illness, by focussing on personalised psychological (after)care.